AZD8075 Single Ascending Dose Study

This study has been terminated.
(After reports of turbidity in urine in 4 of 8 volunteers in the 4th cohort, the study was halted temporarily.)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00787072
First received: November 6, 2008
Last updated: November 30, 2010
Last verified: November 2010
  Purpose

The aim of this study is to assess the safety, tolerability and pharmacokinetics of single ascending oral doses of AZD8075 in healthy male volunteers


Condition Intervention Phase
Healthy Volunteers
Drug: AZD8075
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of AZD8075 in Healthy Male Volunteers

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab) [ Time Frame: Frequent sampling occasions during study days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PK variables [ Time Frame: Frequent sampling occasions during study days ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: October 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD8075
Single dose, the starting dose will be 7 mg, oral suspension, with up to 8 dose escalations not exceeding AstraZeneca pre-defined upper exposure limits.
Placebo Comparator: 2 Drug: Placebo
Oral suspension

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Provision of signed, written and dated informed consent prior to any study specific procedures.
  • Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg.
  • Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for >6 months prior to study start.

Exclusion Criteria:

  • Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject's ability to participate
  • Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs (vital signs (ie, supine BP and pulse) or ECG at baseline, which, in the opinion of the investigator, may put the subject at risk.
  • Participation in another investigational drug study within 3 months before Visit 2 or participation in a method development study (no drug) 1 month prior to Visit 2
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00787072

Locations
Sweden
Research Site
Uppsala, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Eva Pettersson AstraZeneca R&D, Lund, Sweden
Principal Investigator: Wolfgang Kühn Quintiles, Uppsala, Sweden
  More Information

No publications provided

Responsible Party: Christer Hultquist, Medical Science Director, AstraZeneca R&D Lund, Sweden
ClinicalTrials.gov Identifier: NCT00787072     History of Changes
Other Study ID Numbers: D3801C00001
Study First Received: November 6, 2008
Last Updated: November 30, 2010
Health Authority: Sweden: Medical Products Agency

ClinicalTrials.gov processed this record on July 29, 2014